An overview of Torisel and why it is authorised in the EU
Torisel is a medicine used to treat patients with the following types of cancer:
- advanced renal cell carcinoma (a kidney cancer). ‘Advanced’ means that the cancer has started to spread;
- mantle cell lymphoma (a cancer of B cells, a type of white blood cell). Torisel is used in adults when the lymphoma has come back after previous treatment or if other treatments have not worked.
These diseases are rare, and Torisel was designated an ‘orphan medicine’ (a medicine used in rare diseases) on various dates.
Torisel contains the active substance temsirolimus.
Torisel : EPAR - Summary for the public (PDF/84.95 KB)
First published: 22/09/2009
Last updated: 12/04/2018
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This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.
Pfizer Europe MA EEIG
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07/08/2018 Torisel - EMEA/H/C/000799 - T/0071
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Torisel is indicated for the first-line treatment of adult patients with advanced renal-cell carcinoma (RCC) who have at least three of six prognostic risk factors.
Torisel is indicated for the treatment of adult patients with relapsed and / or refractory mantle-cell lymphoma (MCL).
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